CN115038409A - Implantable device for repairing heart valves - Google Patents

Abstract

An implantable device for repairing a heart valve having an annulus and two or more leaflets is provided. An implantable device comprising: a substantially annular support member comprising a longitudinal axis, the substantially annular support member sized to be attachable to an annulus of a heart valve. The implantable device further comprises: a midsection member comprising a longitudinal axis, a distal portion and a proximal portion, the distal portion of the midsection member obliquely passing through the leaflets towards the ventricle such that the midsection member is obliquely attached to the substantially annular support member thereby inducing the leaflets to contact towards the midsection member.

Description

Implantable device for repairing heart valves

RELATED APPLICATIONS

This application claims priority from united states provisional patent application No. 62/930,599 (filed on 5/11/2019) and united states patent application No. 63/109,322 (filed on 3/11/2020), the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates generally to surgical devices and methods for treating dysfunctional heart valves, and more particularly to devices and associated methods for providing valve support to passively assist in preventing or mitigating heart valve regurgitation.

Background

The use of an undersized, intact and rigid annuloplasty ring to reduce the size of the annulus and to coapt the leaflets can be accompanied by over-correction of annular dilation, requiring the use of surgical correction of heart valve regurgitation. Although it has been demonstrated that all correction of valve regurgitation can be done surgically, heart valve regurgitation often recurs after annuloplasty, usually after valve repair.

Disclosure of Invention

According to one embodiment, there is provided an implantable device for repairing a heart valve having an annulus and two or more leaflets, the device comprising: a substantially annular support member comprising a longitudinal axis, the substantially annular support member sized to be attachable to an annulus of the heart valve; and a midsection member comprising a longitudinal axis, a distal end portion and a proximal end portion, the distal end portion of the midsection member being obliquely passed through the leaflets toward the ventricle such that the midsection member is obliquely attached to the substantially annular support member, thereby inducing the leaflets to contact toward the midsection member. The proximal portion of the central member is configured to be placed in an atrium. The apparatus also includes at least one connecting member configured to support the midsection member via the substantially annular support member. The midsection member may have a croissant shape.

According to another embodiment, there is provided an implantable device for repairing a heart valve having an annulus and two or more leaflets, the device comprising: a substantially annular support member comprising a longitudinal axis, the substantially annular support member sized to be attachable to an annulus of the heart valve; and a midsection member comprising a longitudinal axis, a distal end portion, and a proximal end portion, the longitudinal axis of the substantially annular support member being disposed at a predetermined angle to the longitudinal axis of the midsection member such that the midsection member is obliquely attached to the substantially annular support member to induce contact of the leaflets towards the midsection member. The distal end portion of the midsection member is configured to pass through the leaflets of the heart valve into a ventricle while the proximal end portion of the midsection member is placed in an atrium. The entire midsection member is configured to be placed between the leaflets. The entire central member is configured to be placed in the atrium. The entire midsection member is configured to be placed in a ventricle. The predetermined angle is about 0 degrees. The predetermined angle is about 90 degrees. The apparatus also includes at least one connecting member configured to support the midsection member via the substantially annular support member. The midsection member may have a croissant shape.

According to one aspect of the present invention, a method is provided for treating backflow of blood flow through a diseased tricuspid valve. One step of the method includes providing an apparatus comprising a substantially annular support member and a midsection member fixedly coupled thereto. Next, a substantially annular support member is attached to the annulus of the diseased tricuspid valve such that the midsection member extends obliquely to the posterior of the anterior superior leaflet and to the anterior of the posterior and septal leaflets.

In accordance with another aspect of the present invention, a method of treating regurgitation of blood flow through a diseased mitral valve is provided. One step of the method includes providing an apparatus comprising a substantially annular support member and a midsection member fixedly coupled thereto. Next, a substantially annular support member is attached to the annulus of the diseased mitral valve such that the midsection member extends obliquely between the anterior and posterior leaflets.

Drawings

Fig. 1A shows a view of a diseased tricuspid valve with a Regurgitant Orifice (RO).

Fig. 1B shows a view of a diseased mitral valve with a Regurgitant Orifice (RO).

Figure 1C shows a cross-sectional view of the Regurgitant Orifice (RO) and leaflets.

Fig. 2A shows a front view of a device for the tricuspid valve.

Fig. 2B shows a side view of the device of fig. 2A.

Fig. 2C shows a cross-sectional view of the device of fig. 2A implanted in the tricuspid valve.

Fig. 2D shows a front view of an alternative structure of the device for the tricuspid valve of fig. 2A.

Fig. 2E shows a side view of the device of fig. 2D.

Fig. 2F shows a cross-sectional view of the device of fig. 2D implanted in a tricuspid valve.

Fig. 3A shows a front view of an alternative structure of a device for the tricuspid valve.

Fig. 3B shows a side view of the device of fig. 3A.

Fig. 3C shows a cross-sectional view of the device of fig. 3A implanted in the tricuspid valve.

Fig. 3D shows a front view of the alternative structure of fig. 3A for the tricuspid valve.

Fig. 3E shows a side view of the device of fig. 3D.

Fig. 3F shows a cross-sectional view of the device of fig. 3D implanted in the tricuspid valve.

Fig. 4A shows a front view of an alternative structure for a tricuspid valve device.

Fig. 4B shows a side view of the device in fig. 4A.

Fig. 4C shows a cross-sectional view of the device of fig. 4A implanted in the tricuspid valve.

Fig. 4D shows a front view of an alternative configuration of the device of fig. 4A for use with the tricuspid valve.

Fig. 4E shows a side view of the device in fig. 4D.

Fig. 4F shows a cross-sectional view of the device of fig. 4D implanted in a tricuspid valve.

Fig. 5A shows a perspective view of the device of fig. 2A when the tricuspid valve is open.

Fig. 5B shows a perspective view of the device of fig. 2A when the tricuspid valve is closed.

Fig. 5C shows a cross-sectional view of the device of fig. 5B implanted in the tricuspid valve.

Fig. 5D is a perspective view showing the device of fig. 2D when the tricuspid valve is open.

Fig. 5E shows a perspective view of the device of fig. 2D with the tricuspid valve closed.

Fig. 5F shows a cross-sectional view of the device of fig. 5D implanted in the tricuspid valve.

Fig. 6A shows an anterior view of an alternative structure of a tricuspid valve device.

Fig. 6B shows a side view of the device in fig. 6A.

Fig. 6C shows a cross-sectional view of the device of fig. 6A implanted in a tricuspid valve.

Fig. 6D shows a front view of an alternative structure of the device of fig. 6A for use in the tricuspid valve.

Fig. 6E shows a side view of the device in fig. 6D.

Fig. 6F shows a cross-sectional view of the device of fig. 6D implanted in a tricuspid valve.

Fig. 7A shows an anterior view of a mitral valve device.

Fig. 7B shows a side view of the device of fig. 7A.

Fig. 7C shows a cross-sectional view of the device of fig. 7A implanted in a mitral valve.

Fig. 7D shows a front view of an alternative configuration of the device of fig. 7A for use with a mitral valve.

Fig. 7E shows a side view of the device in fig. 7D.

Fig. 7F shows a cross-sectional view of the device of fig. 7D implanted in a mitral valve.

Fig. 8A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 8B shows a side view of the device of fig. 8A.

Fig. 8C shows a cross-sectional view of the device of fig. 8A implanted in a mitral valve.

Fig. 8D shows a front view of an alternative structure of the device of fig. 8A for a mitral valve.

Fig. 8E shows a side view of the device of fig. 8D.

Fig. 8F shows a cross-sectional view of the device of fig. 8D implanted in the mitral valve.

Fig. 9A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 9B shows a side view of the device of fig. 9A.

Fig. 9C shows a cross-sectional view of the device of fig. 9A implanted in a mitral valve.

Fig. 9D shows a front view of the alternative structure of the device of fig. 9A for use with a mitral valve.

Fig. 9E shows a side view of the device of fig. 9D.

Fig. 9F shows a cross-sectional view of the device of fig. 9D implanted in the mitral valve.

Fig. 10A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 10B shows a top view of the device of fig. 10A.

Fig. 10C shows a top view of the device of fig. 10A implanted in the mitral valve.

Fig. 11A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 11B shows a side view of the device of fig. 11 a.

Fig. 11C shows a cross-sectional view of the device of fig. 11A implanted in a mitral valve.

Fig. 12A shows a perspective view of a device implanted in a mitral valve.

Fig. 12B shows another perspective view of the device implanted in the mitral valve.

Fig. 12C shows a perspective view of the device of fig. 12A.

Fig. 12D shows a side view of the device of fig. 12A.

Fig. 13A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 13B shows a side view of the device of fig. 13A.

Fig. 13C shows a cross-sectional view of the device of fig. 13A implanted in a mitral valve.

Fig. 14A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 14B shows a side view of the device of fig. 14A.

Fig. 14C shows a cross-sectional view of the device of fig. 14A implanted in a mitral valve.

Fig. 15A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 15B shows a side view of the device of fig. 15A.

Fig. 15C shows a cross-sectional view of the device of fig. 15A implanted in a mitral valve.

Fig. 16A shows a front view of an alternative structure of a device for the mitral valve.

Fig. 16B shows a side view of the device of fig. 16A.

Fig. 16C shows a cross-sectional view of the device of fig. 16A implanted in the tricuspid valve.

Fig. 17A shows a perspective view of an alternative structure of a device for the tricuspid valve.

Fig. 17B shows a side view of the device of fig. 17A.

Fig. 17C shows a cross-sectional view of the device of fig. 17A implanted in the tricuspid valve.

Fig. 18A shows a front view of an alternative structure of a device for the tricuspid valve.

Fig. 18B shows a side view of the device of fig. 18A.

Fig. 18C shows a cross-sectional view of the device of fig. 18A implanted in the tricuspid valve.

Fig. 19A shows a front view of an alternative structure of a device for the tricuspid valve.

Fig. 19B shows a side view of the device of fig. 19A.

Fig. 19C shows a cross-sectional view of the device of fig. 19A implanted in the tricuspid valve.

Fig. 20A shows a front view of an alternative structure of a device for the tricuspid valve.

Fig. 20B shows a side view of the device of fig. 20A.

Fig. 20C shows a top cross-sectional view of the device of fig. 20A implanted in the tricuspid valve.

Fig. 21A shows an anterior view of an alternative structure of a tricuspid valve device.

Fig. 21B shows a side view of the device of fig. 21A.

Fig. 21C shows a cross-sectional view of the device of fig. 21A implanted in the tricuspid valve.

Fig. 22A shows a front view of an alternative structure of a device for the tricuspid valve.

Fig. 22B shows a side view of the device of fig. 22A.

Fig. 22C shows a cross-sectional view of the device of fig. 22A implanted in the tricuspid valve.

Fig. 23A shows a front view of an alternative structure of a device for the tricuspid valve.

Fig. 23B shows a side view of the device of fig. 23A.

FIG. 23C shows a cross-sectional view of the device of FIG. 23A implanted in a mitral valve.

Detailed Description

To assist in understanding the invention, the drawings illustratively show specific embodiments in which the invention may be practiced. The drawings herein are not drawn to scale or to true scale. For example, the length and width of the components may be adjusted to accommodate the page size.

The present specification relates to devices and methods for treating dysfunctional heart valves (heart valves), and in particular to devices and related methods that help prevent or reduce heart valve regurgitation. Fig. 2A-2C illustrate, as an exemplary embodiment, a device 10 for treating regurgitation of blood flow through a Regurgitation Opening (RO) 3, such as tricuspid valve 1 and mitral valve 2 shown in fig. 1A-1B.

As shown in fig. 1C, a diseased leaflet 4 with a regurgitant orifice 3 is shown in cross-section. The diseased leaflet 4 may include an X-axis and a Y-axis relative to the center of the regurgitant orifice 3. As shown in fig. 1C, the leaflets 4 may be positioned between the atria (atrium) and ventricles (ventricles), which function to prevent backflow of blood from the ventricles to the atria during contraction.

Referring to fig. 2A-2C, a device 10 for a tricuspid valve may include a substantially annular support member 11, a middle member 12, and at least one connecting member 13, the connecting member 13 being fixedly connected between the annular support member 11 and the middle member 12. As described herein, the term "substantially annular" may be used to describe an annular support member 11 having a circular or semi-circular configuration. Thus, the term "substantially annular" may refer to an annular support member 11 that is fully annular, fully circular, elliptical, partially annular, C-shaped (or reverse C-shaped), D-shaped (or reverse D-shaped), U-shaped (or reverse U-shaped), or the like.

As used herein, the term "substantially" may refer to a complete or nearly complete range or degree of an action, feature, characteristic, state, structure, item, or result. For example, a "substantially" annular ring-shaped support member 11 means that the support member 11 may be completely or almost completely annular. In some cases, the exact degree of allowable deviation of the absolute ring state may depend on the specific context. But in general the proximity of the ring states will be the same overall as the result of obtaining the absolute ring state and the overall ring state.

As shown in fig. 2A, for example, the substantially annular support member 11 may be an inverted C-shape sized to be attachable to the tricuspid annulus of the diseased tricuspid valve 1. As shown in fig. 2B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may be configured to have a rigid or semi-rigid structure.

Fig. 2A shows a front view of the device 10. The device 10 may also include at least one midsection member 12. The middle member 12 may be firmly connected to the annular support member 11 in the first position by at least one connecting member 13. As shown in fig. 2A-2C, for example, the midsection member 12 may be connected to the annular support member 11 by at least two connecting members 13. The midsection member 12 may include a longitudinal axis B1. Central member 12 can have a proximal portion 14, a distal portion 15, and an intermediate portion.

Fig. 2B shows a top view of the device 10. The size, shape and configuration of the midsection member 12 are configured to: when the device 10 is implanted at or near the tricuspid annulus of the diseased tricuspid valve 1 as shown in fig. 2C, the middle member 12 expands obliquely through the regurgitant orifice 3. The oblique expansion may be defined as an angle formed between the longitudinal axis A1 of the annular support member and the longitudinal axis B1 of the middle member 12. The angle of oblique dilation may vary from patient to patient.

As shown in fig. 2C, the midsection member 12 may have the following structure as viewed in plan: at an angle between a1 and B1 as shown in fig. 2B, the midsection member 12 may be obliquely expanded through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). The angle may be set to: the midsection member 12 may induce the diseased leaflet 4 to contact towards the midsection member 12. The angle of oblique dilation may vary depending on the patient.

In one example of an embodiment, the angle may be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). The connecting member 13 can be selectively adjusted according to the leaflet structure in order to induce or attract the diseased leaflet 4 into contact towards the midsection member 12. It should be noted that the adjustment mechanism can be operated to adjust the lateral position of the midsection member 12 to adjust the angle defined between a1 and B1.

Fig. 2C shows a top cross-sectional view of the device 10 attached to the tricuspid annulus of a diseased tricuspid valve 1, and the central portion of the midsection member 12 may preferably be disposed at a location where the X-axis and Y-axis intersect within the regurgitant orifice 3 in order to induce the free edges of the leaflets 4 to cling to the midsection member 12 during systole. As shown in FIG. 2C, proximal portion 14 of midsection member 12 may preferably be positioned to be located in the atrium, while distal portion 15 of midsection member 12 may preferably be positioned to be located in the ventricle. It will be appreciated that this arrangement may vary depending on the diseased tricuspid valve structure.

Fig. 5A is a perspective view of fig. 2A. Figure 5B shows that when the diseased tricuspid valve is closed, the attachment of the diseased tricuspid valve leaflets 4 to the midsection member 12 can be induced. As shown in fig. 5A-5B, for example during systole, the distal end portion 15 of the midsection member 12 may preferably be configured to coapt posterior to the anterior superior leaflet 4, and the proximal end portion 14 of the midsection member 12 may be configured to coapt anterior to the posterior and septal leaflets. It should be noted that this engagement may vary depending on the diseased tricuspid valve structure.

Referring to fig. 2A-2C, the midsection member 12 may have a rigid, semi-rigid or flexible structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the actual 3D shape of the patient's leaflets 4. The engagement portion of the midsection member 12 may be oval or elliptical. As shown in fig. 6A-6B, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased tricuspid valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 2A-2C, the midsection member 12 shown in figures 2D-2F may have a more convex or protruding shape depending on the patient's condition.

Fig. 3A-3C illustrate another embodiment for a tricuspid valve. Referring to fig. 3A-3C, the device 10 may include a substantially annular support member 11, a central member 12, and at least one connecting member 13. The connection member 13 may be stably connected between the support member 11 and the middle member 12. For example, as shown in fig. 3A, the substantially annular support member 11 may be inverted C-shaped and may be sized to attach to the tricuspid annulus of the diseased tricuspid valve 1. As shown in fig. 3B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid, semi-rigid or flexible construction.

Fig. 3A shows a front view of the device 10. The device 10 may further comprise at least one midsection member 12, which midsection member 12 may be firmly connected to the annular support member 11 at the first position by at least one connection member 13. For example, as shown in fig. 3A-3C, the midsection member 12 may be connected to the annular support member 11 by two connecting members 13. The midsection member 12 includes a longitudinal axis B1. The midsection member 12 has a proximal end portion 14, a distal end portion 15, and a central portion.

Fig. 3B shows a top view of the device 10. The size, shape, and configuration of the midsection member 12 may be configured to: when the device 10 is implanted at or near the diseased tricuspid valve 1, as shown in fig. 3C, the midsection member 12 may expand obliquely downward through the regurgitant orifice 3. The oblique expansion may be defined as an angle formed between the longitudinal axis A1 of the annular support member and the longitudinal axis B1 of the medial member 12. The angle of oblique dilation may vary from patient to patient.

As shown in FIG. 3C, the top view of midsection member 12 has the following structure: at an angle between a1 and B1 shown in fig. 3B, the midsection member 12 may expand obliquely downward through the ostium 3 (i.e., between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflet 4 to contact towards the midsection member 12. The angle of oblique dilation may vary from patient to patient.

In one example of an embodiment, the angle of a1 and B1 may be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce contact of the diseased leaflet 4 toward the midsection member 12, the connecting member 13 can be selectively adjusted according to the leaflet structure. It should be appreciated that the adjustment mechanism may be operated to adjust the lateral position of the midsection member 12 to adjust the angle defined between a1 and B1.

Fig. 3C shows a top cross-sectional view of the device 10 attached to the tricuspid annulus of a diseased tricuspid valve 1. The central portion of the midsection member 12 is preferably positioned within the ostium 3 where the X-axis and Y-axis intersect to induce the free edges of the leaflets 4 to adhere or contact toward the midsection member 12 during systole. As shown in FIG. 3C, distal portion 15 of midsection member 12 is preferably positioned to be located in the ventricle, while proximal portion 14 of midsection member 12 is preferably positioned to be located in the atrium. It will be appreciated that this arrangement may vary depending on the diseased tricuspid valve structure.

Referring to fig. 3A-3C, the midsection member 12 may have a rigid, semi-rigid or flexible structure. For example, in the case of a midsection member 12 having a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased tricuspid valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 3A-3C, the midsection member 12 shown in figures 3D-3F may have a more convex or protruding shape depending on the patient's condition.

Fig. 4A-4C illustrate another embodiment for a tricuspid valve. Referring to fig. 4A-4C, the device 10 includes a substantially annular support member 11 and a midsection member 12, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 4A, the substantially annular support member 11 may be inverted C-shaped and sized to engage the tricuspid annulus of the diseased tricuspid valve 1. As shown in fig. 4B, the annular support member 11 includes a longitudinal axis a 1. The midsection member 12 includes a longitudinal axis B1. The central member 12 has a proximal end portion 14 and a distal end portion 15.

Fig. 4B shows a top view of the device 10 of fig. 4A. When the device 10 is implanted at or near the diseased tricuspid valve 1, as shown in fig. 4C, the midsection member 12 is sized, shaped, and configured to expand obliquely upward through the regurgitant orifice 3. As shown in fig. 4C, the structure of the midsection member 12 is configured to: at an angle between a1 and B1 as shown in fig. 4B, the midsection member 12 expands obliquely upward through the ostium 3 (i.e., between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflets 4 to come into contact towards the midsection member 12. The oblique expansion may be defined as an angle formed between the longitudinal axis A1 of the annular support member and the longitudinal axis B1 of the medial member 12. The angle of oblique dilation may vary depending on the patient.

In one example of an embodiment, the angle of a1 and B1 may be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure. It should be appreciated that the adjustment mechanism may be operated to adjust the lateral position of the midsection member 12 to adjust the angle defined between a1 and B1.

Fig. 4C shows a top cross-sectional view of the device 10 attached to the tricuspid annulus of a diseased tricuspid valve 1. The central portion of the midsection member 12 is preferably positioned within the ostium 3 at a location where the X-axis and Y-axis intersect to induce the free edges of the leaflets 4 to adhere or contact toward the midsection member 12 during systole. As shown in FIG. 4C, proximal portion 14 of midsection member 12 is preferably positioned to be located in the atrium, while distal portion 15 of midsection member 12 is preferably positioned to be located in the ventricle. It will be appreciated that this arrangement may vary depending on the diseased tricuspid valve structure.

Referring to fig. 4A-4C, the midsection member 12 may have a rigid, semi-rigid, or flexible structure. For example, in the case of a midsection member 12 having a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased tricuspid valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 4A-4C, the midsection member 12 shown in figures 4D-4F may have a more convex or protruding shape depending on the patient's condition.

Fig. 6A-6C illustrate another embodiment for a tricuspid valve. Referring to fig. 6A-6C, the device 10 may include a substantially annular support member 11, a central member 12, and at least one connecting member 13. The connection member 13 may be stably connected between the ring-shaped support member 11 and the middle member 12. For example, as shown in fig. 6A, the substantially annular support member 11 may be inverted C-shaped and may be sized to attach to the tricuspid annulus of the diseased tricuspid valve 1. As shown in fig. 6B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction.

Fig. 6A shows a front view of the device 10. The device 10 may further comprise at least one midsection member 12, which midsection member 12 may be firmly connected to the annular support member 11 at the first position by means of a connecting member 13. The midsection member 12 includes a longitudinal axis B1. Central member 12 has a proximal end portion 14 and a distal end portion 15. Fig. 6B shows a top view of the device 10 of fig. 6A. The size, shape, and configuration of the midsection member 12 may be configured to: when the device 10 is implanted at or near the diseased tricuspid valve 1 as shown in fig. 6C, the midsection member 12 may expand obliquely horizontally through the regurgitant orifice 3.

As shown in FIG. 6C, the top view of the midsection member 12 of FIG. 6A has the following structure: at an angle between a1 and B1 shown in fig. 6B, the midsection member 12 can expand obliquely horizontally through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflet 4 to contact towards the midsection member 12. In one example of an implementation, the angle of a1 and B1 may be about 90 degrees. To bring the diseased leaflet 4 into contact towards the midsection member 12, the size of the midsection member can be selectively adjusted based on the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the intermediate member 12 to adjust the angle defined by A1 and B1.

Fig. 6C shows a top cross-sectional view of the device 10 attached to the tricuspid annulus of a diseased tricuspid valve 1. The central portion of the midsection member 12 is preferably positioned within the ostium 3 where the X-axis and Y-axis intersect to induce the free edges of the leaflets 4 to adhere or contact toward the midsection member 12 during systole. As shown in FIG. 6C, the proximal portion 14 of the central member 12 is preferably configured to be positioned in the atrium, and the distal portion 16 of the central member is preferably configured to be positioned in the ventricle. It will be appreciated that this arrangement may vary depending on the diseased tricuspid valve structure.

Referring to fig. 6A-6C, midsection member 12 may have a rigid, semi-rigid, or flexible structure. For example, in the case of a midsection member 12 having a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the central member 12 may be oval or elliptical. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased tricuspid valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 6A-6C, the midsection member 12 shown in figures 6D-6F may have a more convex or protruding shape depending on the patient's condition. As another example, the midsection member 12 may be shaped like a croissant.

Fig. 7A-7C illustrate an embodiment for a mitral valve. Referring to fig. 7A-7C, the device 10 includes a substantially annular support member 11, a central member 12, and at least one connecting member 13, the connecting member 13 being fixedly connected between the annular support member 11 and the central member 12. For example, as shown in fig. 7A, the substantially annular support member 11 may be U-shaped, sized to attach to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 7B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid, semi-rigid or flexible construction.

Fig. 7A shows a front view of the device 10. The device 10 may further comprise at least one midsection member 12, which midsection member 12 may be firmly connected to the annular support member 11 at the first position by means of a connecting member 13. The midsection member 12 includes a longitudinal axis B1. Central member 12 has a proximal end portion 14 and a distal end portion 15. Fig. 7B shows a top view of the device 10 of fig. 7A. The size, shape, and configuration of the midsection member 12 may be configured to: as shown in fig. 7C, when the device 10 is implanted at or near the diseased mitral valve 2, the midsection member 12 can expand upward through the regurgitant orifice 3. As shown in fig. 7C, the midsection member 12 has the following structure: at an angle between a1 and B1 shown in fig. 7B, the midsection member 12 may expand upward through the ostium 3 (i.e., between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflet 4 to contact towards the midsection member 12.

In one example of an embodiment, the angle of a1 and B1 may be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce contact of the diseased leaflet 4 toward the midsection member 12, the connecting member 13 can be selectively adjusted according to the leaflet structure. It should be appreciated that the adjustment mechanism can be operated to adjust the lateral position of midsection member 12 to adjust the angle defined between a1 and B1.

Fig. 7C shows a top cross-sectional view of the device 10 attached to the mitral annulus of a diseased mitral valve. The central portion of the midsection member 12 is preferably positioned within the ostium 3 where the X-axis and Y-axis intersect to induce the free edges of the leaflets 4 to adhere or contact toward the midsection member 12 during systole. When the proximal portion of the middle member 12 is disposed in the atrium, the pressure between the proximal portion and the adjacent leaflets increases during systole. At the same time, the distal portion of midsection member 12 is disposed within the ventricle, and the pressure between the distal portion and the adjacent leaflets is reduced during systole. The above interaction attracts and enhances coaptation between the diseased leaflets and the midsection member 12 during systole.

For example, as shown in fig. 7C, the proximal portion of the midsection member 12 is disposed within the atrium for inducing the adjacent free edges of the diseased leaflets to adhere toward the midsection member 12 during systole. At the same time, the distal portion of the midsection member 12 is disposed within the ventricle for inducing the adjacent free edges of the diseased leaflets to adhere toward the midsection member 12 during systole. It will be appreciated that this arrangement may vary depending on the configuration of the diseased mitral valve.

Referring to fig. 7A-7C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased tricuspid valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 7A-7C, the midsection member 12 shown in figures 7D-7F may have a more convex or protruding shape depending on the patient's condition.

Fig. 8A-8C illustrate another embodiment for a mitral valve. Referring to fig. 8A-8C, the device 10 may include a substantially annular support member 11, a central member 12, and at least one connecting member 13. The connection member 13 may be stably connected between the ring-shaped support member 11 and the middle member 12. For example, as shown in fig. 8A, the substantially annular support member 11 may be U-shaped and may be sized to attach to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 8B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction.

Fig. 8A shows a front view of the device 10. The device 10 further comprises at least one midsection member 12, which midsection member 12 is firmly connected to the annular support member 11 at a first position by means of a connecting member 13. The midsection member 12 includes a longitudinal axis B1. Central member 12 has a proximal end portion 14 and a distal end portion 15.

Fig. 8B shows a top view of the device 10 of fig. 8A. The size, shape and configuration of the midsection member 12 are configured to: when the device 10 is implanted at or near the diseased mitral valve 2, the middle member 12 expands downward through the regurgitant orifice 3, as shown in fig. 8C. As shown in fig. 8C, the structure of the midsection member 12 is configured to: at an angle between a1 and B1 as shown in fig. 8B, the midsection member 12 expands downward through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflet 4 to contact towards the midsection member 12.

In one example of an implementation, the angle of a1 and B1 may be between about 10 degrees to about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure. It should be appreciated that the adjustment mechanism may be operated to adjust the lateral position of the midsection member 12 to adjust the angle defined between a1 and B1.

Fig. 8C shows a top cross-sectional view of the device 10 attached to the mitral annulus of a diseased mitral valve. The central portion of the midsection member 12 is preferably positioned within the ostium 3 at a location where the X-axis and Y-axis intersect to induce the free edges of the leaflets 4 to adhere (or contact) toward the midsection member 12 during systole. When the proximal portion of the middle member 12 is disposed in the atrium, the pressure between the proximal portion and the adjacent leaflets increases during systole. While the distal portion of the midsection member 12 is disposed within the ventricle, the pressure between the distal portion and the adjacent leaflets is reduced during systole. The above interaction attracts and enhances coaptation between the diseased leaflets and the midsection member 12 during systole. It will be appreciated that this arrangement may vary depending on the diseased mitral valve structure.

Referring to fig. 8A-8C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 8A-8C, the midsection member 12 shown in figures 8D-8F may have a more convex or protruding shape depending on the patient's condition.

Fig. 9A-9C illustrate another embodiment for a mitral valve. Referring to fig. 9A-9C, the device 10 includes a substantially annular support member 11 and a midsection member 12, the midsection member 12 being fixedly attached to the annular support member 11. For example, as shown in fig. 9A, the substantially annular support member 11 may be U-shaped, sized to attach to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 9B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid, semi-rigid or flexible construction.

As shown in FIG. 9B, the midsection member 12 includes a longitudinal axis B1. The central member 12 has a proximal end portion 14 and a distal end portion 15. FIG. 9B shows a top view of the device 10 of FIG. 9A, with the midsection member 12 being sized, shaped, and configured to: when the device 10 is implanted at or near the diseased mitral valve 2, the midsection member 12 expands upward through the regurgitant orifice 3, as shown in fig. 9C.

As shown in fig. 9C, the midsection member 12 is configured to: at an angle between a1 and B1 as shown in fig. 9B, the midsection member 12 expands upward through the regurgitant orifice 3 (i.e. between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflet 4 to contact towards the midsection member 12. In one example of an embodiment, the angle of a1 and B1 may be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure. It should be appreciated that the adjustment mechanism can be operated to adjust the lateral position of midsection member 12 to adjust the angle defined between a1 and B1.

Fig. 9C shows a top down cross section of the device 10 attached to the mitral annulus of a diseased mitral valve 1. The central portion of the midsection member 12 is preferably disposed at a position where the X-axis and Y-axis intersect within the ostium 3 to induce the free edges of the leaflets 4 to adhere or contact toward the midsection member 12 during systole. When the proximal end portion 14 of the middle member 12 is disposed within the atrium, the pressure between the proximal end portion and the adjacent leaflets increases. Meanwhile, when the distal end portion 15 of the intermediate member 12 is disposed within the ventricle, the pressure between the distal end portion and the adjacent leaflets is reduced during systole.

During systole, the above interaction attracts and enhances coaptation between the diseased leaflet and the midsection member 12. It will be appreciated that this arrangement may vary depending on the diseased mitral valve structure.

Referring to fig. 9A-9C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 9A-9C, the midsection member 12 shown in figures 9D-9F may have a more convex or protruding shape depending on the patient's condition.

Fig. 10A-10C illustrate another embodiment for a mitral valve. Referring to fig. 10A-10C, the device 10 includes a substantially annular support member 11 and a central member 12, with a connecting member 13 fixedly connected to the support member 11 and the central member 12. For example, as shown in fig. 10A, the substantially annular support member 11 may be U-shaped and sized to attach to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 10B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction.

As shown in FIG. 10B, the midsection member 12 includes a longitudinal axis B1. The central member 12 has a proximal end portion and a distal end portion 15. FIG. 10B shows a top view of the device 10 of FIG. 10A, with the midsection member 12 being sized, shaped and configured to: when the device 10 is implanted at or near the diseased mitral valve 2, the midsection member 12 expands horizontally toward the ventricle through the regurgitant orifice 3, as shown in fig. 10C.

As shown in fig. 10C, the midsection member 12 is configured to: at the angle shown in fig. 10B between a1 and B1, the midsection member 12 expands horizontally through the regurgitant orifice 3 (i.e. between the diseased leaflets 4). This angle enables the midsection member 12 to induce the diseased leaflet 4 to contact towards the midsection member 12. In one example of an embodiment, the angle of a1 and B1 may be about 80 degrees to about 100 degrees (e.g., about 90 degrees). To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure. It should be appreciated that the adjustment mechanism may be operated to adjust the lateral position of the midsection member 12 to adjust the angle defined between a1 and B1.

Referring to fig. 10A-10C, the midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape that corresponds to the 3D shape of the leaflets 4. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation. For example, relative to the midsection members shown in figures 10A-10C, the midsection member 12 shown in figures 10D-10F may have a more convex or protruding shape depending on the patient's condition.

Fig. 11A-11C illustrate another embodiment for a mitral valve. Referring to fig. 11A-11C, the device 10 includes a substantially annular support member 11 and a central member 12, with a connecting member 13 fixedly connected to the support member 11 and the central member 12. For example, as shown in fig. 11A, the substantially annular support member 11 may be U-shaped and sized to attach to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 11B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction.

The midsection member 12 includes a longitudinal axis B1. Fig. 11B shows a top view of the device 10 of fig. 11A. When the device 10 is implanted at or near the diseased mitral valve 2, the central member 12 is sized, shaped, and configured to be positioned within the atrium, as shown in FIG. 11C. As shown in FIG. 11C, the central member 12 is configured to be positioned in the atrium. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 11A-11C, midsection member 12 may have a rigid or semi-rigid mechanism. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 12A-12D illustrate another embodiment for a mitral valve. Referring to fig. 12A-12D, the device 10 includes a substantially annular support member 11 and a midsection member 12, the midsection member 12 being fixedly connected to the support member 11 and the connecting member 13. For example, as shown in fig. 12A, the substantially annular support member 11 may be U-shaped and sized to attach to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B.

As shown in FIG. 12C, the central member 12 is configured such that the central member 12 is positioned in the atrium. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 12A-12D, the midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation

Fig. 13A-13C illustrate another embodiment for a mitral valve. Referring to fig. 13A-13C, the device 10 includes a substantially annular support member 11, a midsection member 12, and a connecting member 13, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 13A, the substantially annular support member 11 may be U-shaped and may be sized to be attachable to the mitral annulus of a diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 13B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction.

The midsection member 12 includes a longitudinal axis B1. Fig. 13B shows a top view of the device 10 of fig. 13A. When the device 10 is implanted at or near the diseased mitral valve 2, as shown in fig. 13C, the midsection member 12 is sized, shaped and configured to be positioned within the leaflets 4. As shown in fig. 13C, the midsection member 12 is configured to be positioned within the leaflet 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 13A-13C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The midsection member 12 may have a 3D shape corresponding to the 3D shape of the leaflets 4 the coaptation portion of the midsection member 12 may be elliptical. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the structure of the diseased mitral valve to achieve optimal leaflet coaptation.

Fig. 14A-14C illustrate another embodiment for a mitral valve. Referring to fig. 14A-14C, the device 10 includes a substantially annular support member 11, a midsection member 12, and a connecting member 13, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 14A, the substantially annular support member 11 may be U-shaped and may be sized to be attachable to the mitral annulus of a diseased mitral valve 2, as shown in fig. 1B. As shown in fig. 14B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction.

The midsection member 12 includes a longitudinal axis B1. Fig. 14B shows a top view of the device 10 of fig. 14A. When the device 10 is implanted at or near the diseased mitral valve 2, as shown in fig. 14C, the midsection member 12 is sized, shaped, and configured to be positioned within the diseased leaflet 4. As shown in fig. 14C, the midsection member 12 is configured to be positioned within the leaflet 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 14A-14C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the structure of the diseased mitral valve to achieve optimal leaflet coaptation.

Fig. 15A-15C illustrate another embodiment for a mitral valve. Referring to fig. 15A-15C, the device 10 includes a substantially annular support member 11, a midsection member 12, and a connecting member 13, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 15A, the substantially annular support member 11 may be U-shaped and may be sized to be attachable to the mitral annulus of a diseased mitral valve 2, as shown in fig. 1B.

As shown in fig. 15B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. Fig. 15B shows a top view of the device 10 of fig. 15A. When the device 10 is implanted at or near the diseased mitral valve 2, as shown in fig. 15C, the midsection member 12 is sized, shaped, and configured to be positioned near the ostium 3 toward the atrium. As shown in fig. 15C, the midsection member 12 is configured to be positioned adjacent the leaflets 4 towards the atrium. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 15A-15C, the midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 16A-16C illustrate another embodiment for a tricuspid valve. Referring to fig. 16A-16C, the device 10 includes a substantially annular support member 11, a midsection member 12, and a connecting member 13, the midsection member 12 being fixedly connected to the support member 11. For example, as shown in fig. 16A, the substantially annular support member 11 may be inverted C-shaped and sized to be attachable to the tricuspid annulus of the diseased tricuspid valve 1, as shown in fig. 1A.

As shown in fig. 16B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. Fig. 16B shows a top view of the device 10 of fig. 16A. As shown in fig. 16C, when the device 10 is implanted at or near the diseased tricuspid valve 1, the midsection member 12 is sized, shaped, and configured for placement over the leaflets, or the leaflets, toward the atrium. As shown in FIG. 16C, the midsection member 12 is configured such that the midsection member 12 is positioned posterior to the looped support member and toward the atrium. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 16A-16C, the midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 17A-17B are perspective views of the device of fig. 16A. As shown in fig. 17C, the midsection member 12 is configured to: the central member 12 is positioned posterior to the annular support member and toward the atrium. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Fig. 18A-18C illustrate another embodiment for a tricuspid valve. Referring to fig. 18A-18C, the device 10 includes a substantially annular support member 11, a midsection member 12, and a connecting member 13, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 18A, the substantially annular support member 11 may be inverted C-shaped and sized to be attachable to the tricuspid annulus of the diseased tricuspid valve 1, as shown in fig. 1A.

As shown in fig. 18B, the annular support member 11 includes a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. Fig. 18B shows a top view of the device 10 of fig. 18A. The size, shape and configuration of the midsection member 12 are configured to: as shown in fig. 18C, when the device 10 is implanted at or near the diseased tricuspid valve 1, the midsection member 12 is positioned within the leaflets 4 (the regurgitant orifices 3). As shown in fig. 18C, the midsection member 12 is configured such that the midsection member 12 is located within the leaflets 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 18A-18C, the midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. Alternatively, the midsection member 12 may have a convex shape relative to axis B1. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 19A-19C illustrate another embodiment for a tricuspid valve. Referring to fig. 19A-19C, the device 10 may include a substantially annular support member 11, a midsection member 12, and a connecting member 13, the midsection member 12 being securely connected to the annular support member 11. For example, as shown in fig. 19A, the substantially annular support member 11 may be inverted C-shaped and sized to attach to the tricuspid annulus of the diseased tricuspid valve 1, as shown in fig. 1A.

As shown in fig. 19B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. FIG. 19B shows a top view of the device 10 of FIG. 19A, with the midsection member 12 being sized, shaped, and configured to: when the device 10 is implanted at or near the diseased tricuspid valve 1, the midsection member 12 is positioned near the ostium toward the atrium, as shown in fig. 19C. As shown in fig. 19C, the midsection member 12 is configured to: the central member 12 is located adjacent the leaflets 4 towards the atrium. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 19A-19C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 20A-20C illustrate another embodiment for a tricuspid valve. Referring to fig. 20A-20C, the device 10 may include a substantially annular support member 11 and a midsection member 12, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 20A, the substantially annular support member 11 may be inverted C-shaped and may be sized to attach to the annular space of the diseased tricuspid valve 1, as shown in fig. 1A.

As shown in fig. 20B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. Fig. 20B shows a top view of the device 10 of fig. 20A. The size, shape and configuration of the midsection member 12 are configured to: as shown in fig. 20C, when the device 10 is implanted at or near the diseased tricuspid valve 1, the midsection member 12 may be positioned within the leaflets 4. As shown in fig. 20C, the midsection member 12 is configured such that the midsection member 12 can be positioned within the leaflets 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 20A-20C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 21A-21C illustrate another embodiment for a tricuspid valve. Referring to fig. 21A-21C, the device 10 may include a substantially annular support member 11 and a central member 12, the central member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 21A, the substantially annular support member 11 may be inverted C-shaped and sized to attach to the annular space of the diseased tricuspid valve 1, as shown in fig. 1A.

As shown in fig. 21B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. Fig. 21B shows a top view of the device 10 of fig. 21A. The size, shape and configuration of the midsection member 12 is configured to: when device 10 is implanted at or near diseased tricuspid valve 1, midsection member 12 is positioned toward the atrium, near the regurgitant orifice, as shown in fig. 21C. As shown in fig. 21C, the midsection member 12 may be configured to: the midsection member 12 faces the atrium close to the leaflets 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 21A-21C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 22A-22C illustrate another embodiment for a tricuspid valve. Referring to fig. 22A-22C, the device 10 may include a substantially annular support member 11 and a midsection member 12, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 22A, the substantially annular support member 11 may be inverted C-shaped and may be sized to attach to the annular space of the diseased tricuspid valve 1, as shown in fig. 1A.

As shown in fig. 22B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. FIG. 22B shows a top view of the device 10 of FIG. 22A, with the midsection member 12 being sized, shaped, and configured to: when the device 10 is implanted at or near the diseased tricuspid valve 1, as shown in fig. 22C, the midsection member 12 is oriented toward the atrium near the regurgitant orifice and lies in the same plane as the annular support member. As shown in fig. 22C, the midsection member 12 is configured such that the midsection member 12 faces the atrium adjacent to the leaflets 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 22A-22C, the midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjusted to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

Fig. 23A-23C illustrate another embodiment for a mitral valve. Referring to fig. 23A-23C, the device 10 may include a substantially annular support member 11 and a midsection member 12, the midsection member 12 being fixedly connected to the annular support member 11. For example, as shown in fig. 23A, the substantially annular support member 11 may be U-shaped and sized to be attachable to the mitral annulus of the diseased mitral valve 2, as shown in fig. 1B.

As shown in fig. 23B, the annular support member 11 may include a longitudinal axis a 1. The substantially annular support member 11 may have a rigid or semi-rigid construction. Fig. 23B shows a top view of the device 10 of fig. 23A. The size, shape and configuration of the midsection member 12 are configured to: as shown in fig. 23C, when the device 10 is implanted at or near the diseased mitral valve 1, the midsection member 12 can be positioned within the leaflets 4. As shown in fig. 23C, the midsection member 12 can be configured such that the midsection member 12 can be positioned over the leaflets 4. To induce the diseased leaflet 4 to come into contact towards the midsection member 12, the midsection member 12 can be selectively sized according to the leaflet structure.

Referring to fig. 23A-23C, midsection member 12 may have a rigid or semi-rigid structure. For example, where the midsection member 12 has a semi-rigid structure, the midsection member 12 may be bent or adjustable to various positions. The engagement portion of the midsection member 12 may be oval. It should be understood that the stiffness and shape of the midsection member 12 may be varied depending on the diseased mitral valve structure to achieve optimal leaflet coaptation.

The description and examples set forth herein are intended to be illustrative of the invention and are not intended to be limiting. Each disclosed aspect and embodiment of the invention may be considered alone or in combination with other aspects, embodiments, and variations of the invention. Further, the steps of the methods of the present invention are not limited to any particular order unless otherwise specified. Modifications of the disclosed embodiments, which incorporate the spirit and content of the invention, will occur to those skilled in the art and are intended to be within the scope of the invention.

Claims (13)

1. An implantable device for repairing a heart valve having an annulus and two or more leaflets, the device comprising:

a substantially annular support member comprising a longitudinal axis, the substantially annular support member sized to be attachable to an annulus of the heart valve; and

a midsection member comprising a longitudinal axis, a distal end portion and a proximal end portion, the distal end portion of the midsection member being obliquely passed through the leaflets toward a ventricle such that the midsection member is obliquely attached to the substantially annular support member, thereby inducing the leaflets to contact toward the midsection member.

2. The device of claim 1, wherein the proximal portion of the middle member is configured to be placed in an atrium.

3. The apparatus of claim 1, further comprising at least one connecting member configured to support the midsection member via the substantially annular support member.

4. The device of claim 1, wherein the midsection member has a croissant shape.

5. An implantable device for repairing a heart valve having an annulus and two or more leaflets, the device comprising:

a substantially annular support member comprising a longitudinal axis, the substantially annular support member sized to be attachable to an annulus of the heart valve; and

a midsection member comprising a longitudinal axis, a distal end portion, and a proximal end portion, the longitudinal axis of the substantially annular support member being disposed at a predetermined angle to the longitudinal axis of the midsection member such that the midsection member is obliquely attached to the substantially annular support member to induce contact of the leaflets toward the midsection member.

6. The device of claim 5, wherein the distal end portion of the midsection member is configured to pass through the leaflets of the heart valve into a ventricle while the proximal end portion of the midsection member is placed in an atrium.

7. The device of claim 5, wherein the entire midsection member is configured to be placed between the leaflets.

8. The device of claim 5, wherein the entire central member is configured to be placed in the atrium.

9. The device of claim 5, wherein the entire midsection member is configured to be placed in a ventricle.

10. The apparatus of claim 5, wherein the predetermined angle is about 0 degrees.

11. The apparatus of claim 5, wherein the predetermined angle is about 90 degrees.

12. The apparatus of claim 5, further comprising at least one connecting member configured to support the midsection member via the substantially annular support member.

13. The device of claim 5, wherein the midsection member has a croissant shape.

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